Women of childbearing potential: Women of childbearing potential have to use effective contraception during (and up to 6 months after) treatment.
Pregnancy: There are no clinical trial data on the use of Avastin Roche in pregnant women. Studies in animals have shown reproductive toxicity including malformations (see Pharmacology: Toxicology: Preclinical Safety Data under Actions). IgGs are known to cross the placenta, and Avastin Roche is anticipated to inhibit angiogenesis in the foetus, and thus is suspected to cause serious birth defects when administered during pregnancy. In the post-marketing setting, cases of foetal abnormalities in women treated with bevacizumab alone or in combination with known embryotoxic chemotherapeutics have been observed (see Adverse Reactions). Avastin Roche is contraindicated in pregnancy (see Contraindications).
Breast-feeding: It is not known whether bevacizumab is excreted in human milk. As maternal IgG is excreted in milk and bevacizumab could harm infant growth and development (see Pharmacology: Toxicology: Preclinical Safety Data under Actions), women must discontinue breast-feeding during therapy and not breast-feed for at least six months following the last dose of Avastin Roche.
Fertility: Repeat dose toxicity studies in animals have shown that bevacizumab may have an adverse effect on female fertility (see Pharmacology: Toxicology: Preclinical Safety Data under Actions). In a phase III trial in the adjuvant treatment of patients with colon cancer, a substudy with premenopausal women has shown a higher incidence of new cases of ovarian failure in the bevacizumab group compared to the control group. After discontinuation of bevacizumab treatment, ovarian function recovered in the majority of patients. Long term effects of the treatment with bevacizumab on fertility are unknown.